Resident Duty Hour Rules Focus of National Research Trials Now Set to Launch

In mid-March, the Accreditation Council for Graduate Medical Education (ACGME) announced to the GME community that preliminary work had begun on two national multicenter trials designed to investigate the impact of resident duty hour limits instituted in 2011.

In a letter dated March 13(www.acgme.org), ACGME CEO Thomas Nasca, M.D., expressed his support for the research efforts and urged cooperation from the greater GME community, noting that such engagement in the research would be essential.

"The ACGME looks forward with great anticipation to the results of these important research projects," said Nasca. "We encourage internal medicine and general surgery program directors and faculty to consider participation in the trials and their sponsoring institutions to approve their participation."

The letter explained that two groups of investigators approached the ACGME and petitioned the organization for a waiver of certain duty hour standards (excluding core standards), and the ACGME approved the proposed waiver.

Story Highlights

The Accreditation Council for Graduate Medical Education (ACGME) recently alerted the graduate medical education community to the startup of two national multicenter trials aimed at studying the effects of the ACGME's 2011 resident duty hour regulations.

The ACGME granted two groups of investigators a waiver of certain duty hour standards to conduct the research; the investigators will focus their efforts on internal medicine and general surgery residency programs.

Although family medicine programs are not included in the trials, ACGME CEO Thomas Nasca, M.D., said the results "will have a degree of validity across other specialties."

That approval was the green light needed to move ahead with the iCompare trial(www.icomparestudy.com) (Comparative Effectiveness of Models Optimizing Patient Safety and Resident Education), a randomized crossover study that will involve 40-50 internal medicine residency programs and run through June 2017, with data analysis expected to be completed in 2019.

Data collection for the surgical residents trial, dubbed the FIRST trial(surgapps.fsm.northwestern.edu) (Flexibility In Duty Hour Requirements for Surgical Trainees), will commence on July 1, and the active period of the study is expected to end in October 2015. Data analysis will continue into 2016.

Nasca made it clear that the ACGME was not involved in the design or implementation of the trials and would not be involved in the interpretation or publication of any results. The ACGME did agree to provide "seed funding" for the two trials using interest from its reserves (but no current accreditation fee revenue).

Family physicians likely remember that the ACGME's Duty Hours Task Force implemented new rules in July 2011. Those regulations stipulate that first-year residents (interns) can spend no longer than 16 consecutive hours in the hospital and can work no more than six consecutive days. Senior residents can be scheduled for a maximum of 24 continuous hours on duty.

Debate about the effectiveness and unintended consequences of those 2011 rules has raged among residents, faculty members and throughout the GME community since the regulations were put into place.

"I do not believe that I am alone in the assertion that we need large multicenter trials to address key questions concerning the effects of duty hour standards on patient care and safety and the development of the physician," wrote Nasca. "The ACGME, who promulgates these regulations, aspire to use evidence to modify these standards."

In an interview with AAFP News, Nasca reiterated that the pending research was of utmost importance to everyone invested in the GME community.

"There is a consensus, supported by recent publications, that certain components of our duty hour standards may not be having the intended impact," said Nasca. "The ACGME believes that, to the extent possible, these standards should be driven by evidence, and multicenter controlled trials provide us the greatest opportunity to obtain reliable and generalizable information."

Although family medicine programs were not chosen to participate in the trials, the results "will have a degree of validity across other specialties," said Nasca.

For its part, the Academy is pleased with the prospect of legitimate research helping answer questions that have arisen about resident duty hours, said Stan Kozakowski, M.D., director of the AAFP Division of Medical Education.

"Bottom line: Yes, we are in favor of this research and the evidence it may bring to light regarding the latest duty hours regulations. This is long overdue," said Kozakowski.

"The concern voiced by many in the GME community when the current set of duty hours was instituted was that there was little evidence to suggest that the duty hours would protect patients or residents," he added.

Furthermore, at least one previous study highlighted concerns by residents that duty hour limits were creating more patient handoffs, which, in turn, could create a scenario that increased medical errors, said Kozakowski.

Both Kozakowski and Nasca agreed that much of the literature that served as a framework for the current duty hour standards was extrapolated from laboratory sleep studies and anecdotal reports from individual institutions and, therefore, lacked the statistical power needed to explore the real issues of patient safety and the effectiveness of residents' training.

"The studies just announced will be the first of their kind to actually try to obtain hard evidence as to what makes a difference when it comes to controlling residents' work hours," said Kozakowski.